Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
This recall has been terminated (originally issued August 19, 2008).
- Company
- Baxa Corporation
- Recall Initiated
- February 11, 2008
- Posted
- August 19, 2008
- Terminated
- March 16, 2012
- Recall Number
- Z-1371-2008
- Quantity
- 221 units
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Flush solution from TPN compounder may be added to patient's TPN bag.
Distribution
Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand.
Lot / Code Info
Model 071B-RS232, all serial numbers
Root Cause
Software design
Action Taken
Consignees were notified by letter (Exacta-Mix Compounder Software Safety Alert) on 02/11/2008 advising them of the necessity to install a waste bag prior to a machine flush.
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